LAS VEGAS– PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the empty capsule material that makes up its CypCaps™ pancreatic cancer product does not cause skin irritation.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, “We continue to demonstrate that our pancreatic cancer product is safe and performs just as we presented it in the Investigational New Drug application (IND) we submitted to the U.S. Food and Drug Administration (FDA). This latest positive data on the CypCaps product is one more example that brings us closer to updating our full package of information to address the FDA’s comments on our initial IND submission.
“This latest study demonstrates conclusively that the capsule material is not an irritant to the skin and confirms previously submitted data that the capsule material of our CypCaps product is inert. This result strengthens one of our responses to the FDA concerning our IND requesting a clinical trial for locally advanced, inoperable pancreatic cancer.”
The skin irritation study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules for intracutaneous reactivity in New Zealand white rabbits. The study was performed in compliance with the OECD Principles of Good Laboratory Practice [C(97)186/Final and ENV/MC/CHEM (98)17] and in accordance with ISO 10993 Part 10:2010(E). The extracts were injected intracutaneously at five different sites on the anterior part of the trunk of the rabbits, and the animals were observed for 3 days. After injection, there were no clinical signs of toxicity or mortality in any of the animals. Furthermore, no treatment-related changes were seen in the body weights of the rabbits after administration of the empty capsule extract. Importantly, none of the animals revealed treatment-related skin reactions during the 72-hour observation period. Thus, it was concluded that the extracts of empty cellulose sulphate capsules are not a skin irritant in the New Zealand white rabbits.
